This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the ethicon omnex surgical sealant. The device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
| Device | ETHICON OMNEX SURGICAL SEALANT |
| Generic Name | Sealant, Polymerizing |
| Applicant | ETHICON, INC. |
| Date Received | 2006-10-26 |
| Decision Date | 2010-06-03 |
| Notice Date | 2010-06-11 |
| PMA | P060029 |
| Supplement | S |
| Product Code | NBE |
| Docket Number | 10M-0285 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ETHICON, INC. route 22 West somerville, NJ 08876 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060029 | Original Filing | |
| S005 | 2013-01-08 | Normal 180 Day Track |
| S004 | 2012-05-29 | 30-day Notice |
| S003 | 2011-06-29 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2010-07-09 | Real-time Process |